Have routine FDA inspections resumed in any capacity? If not, what can industry members expect in 2021 amidst COVID-19? At the onset of the COVID-19 pandemic in 2020, FDA announced a temporary halt to on-site facility inspections. With few exceptions, the agency made...
The U.S. Supreme Court has settled its fate and denied a petition for a writ of certiorari filed by a supplement manufacturer Hi-Tech Pharmaceuticals and its owner, Jared Wheat. The nation’s highest court has rejected a request to review a case involving the legality...
The owner of a North Carolina-based sports supplement company Musclegen pleaded guilty to selling unapproved drugs and agreed to forfeit the money earned from the illegal business. Selective androgen receptor modulators (SARMs) are drugs under development for...
As COVID-19 drives continued demand for immune booster dietary supplements, new disruptions in the supply chain emphasize the need for quality assurance. The COVID-19 pandemic has been an accelerator for the dietary supplement industry, with sales at record-breaking...
When selling food, cosmetics, drugs, and medical devices, you think beyond the figures of your sales and the performance of your product in the market. You must also keep up with the various rules and regulations established by the Food and Drug Administration (FDA)...